HCC - Hepatocellular CarcinomaSOLACENCT07141056
The Impact of Emotional Stress on Immunotherapy Outcomes in Liver Cancer Patients: A Multi-Cohort Study
An observational study of HCC - Hepatocellular Carcinoma and Psychological Distress, run by Guilin Medical University, China at 5 sites in China.
Trial summary
The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCC - Hepatocellular Carcinoma, Psychological Distress, Immune Checkpoint Inhibitors (ICIs)
- What is being tested?
- Psychological Stress Status
- How many people
- 700 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2025to 31 Dec 2027
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients diagnosed with hepatocellular carcinoma (HCC) who are candidates for immune checkpoint inhibitor therapy. This includes three distinct groups: patients with unresectable HCC who are eligible for first-line immunotherapy (BCLC stage B or C disease), patients with surgically resected HCC who are candidates for adjuvant immunotherapy and patients with potentially resectable HCC who are candidates for neoadjuvant immunotherapy . The study will enroll participants regardless of gender, ethnicity, socioeconomic status, education level, or insurance status. A total of 700 participants will be enrolled across all three cohorts from multiple tertiary hospitals.
Who may be able to join
- Age ≥ 18 years
- Able to complete psychological questionnaires
- Child-Pugh liver function class A
- ECOG performance status ≤ 1
- Signed informed consent
- Expected survival > 3 months
Show all 30Show fewer
- Diagnosed with unresectable HCC by pathology or imaging
- BCLC stage B or C
- Has at least one measurable lesion (mRECIST)
- About to receive first-line ICI treatment
- Age ≥ 18 years
- Able to complete psychological questionnaires
- Child-Pugh liver function class A
- ECOG performance status ≤ 1
- Signed informed consent
- Expected survival > 3 months
- Pathologically confirmed HCC after curative surgery
- Pathological stage II or III (AJCC 8th edition)
- Will start adjuvant ICI therapy within 4-6 weeks after surgery
- Expected survival > 12 months
- Age ≥ 18 years
- Able to complete psychological questionnaires
- Child-Pugh liver function class A
- ECOG performance status ≤ 1
- Signed informed consent
- Expected survival > 3 months
- Diagnosed with resectable HCC by pathology or imaging
- Has at least one measurable lesion (RECIST 1.1)
- About to receive neoadjuvant ICI treatment
- Expected survival > 12 months
Who cannot join
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Unable to complete psychological assessments
- Previous systemic anti-tumor therapy
- Symptomatic brain metastases
Show all 23Show fewer
- Child-Pugh score > 7
- Cohort 2 (SOLACE-2):
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Unable to complete psychological assessments
- Residual lesions after surgery
- Child-Pugh score B or C
- Cohort 3 (SOLACE-3):
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Severe cardiac, pulmonary, or renal dysfunction
- Concurrent malignancy
- Unable to complete psychological assessments
- Previous systemic anti-tumor therapy
- Symptomatic brain metastases
- Child-Pugh score B or C
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
YAQUN YU, MD, +8615807739295, yyq0129@glmc.edu.cn
Lin Ye, MD, 18172681387, yelin@stu.glmc.edu.cn
- Recruiting
The Second Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001
Xueyao Wang, MM, +86 18172681202, wangxueyao@glmc.edu.cn
Hongbin Yao, MM
- Recruiting
Shaoyang Central Hospital
Shaoyang, Hunan, 422000
Jiaye Liao, MM, +86 15773969392, liaojiaye@163.com
Jiaye Liao, MM
- Recruiting
The First Affiliated Hospital of Shaoyang College
Shaoyang, Hunan, 422000
Ali M, MM, +86 19973988716, moali@syxy.edu.cn
Ali Mo, MM
- Recruiting
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000
Shigang Duan, MD, +8618426429995, duanshigang@sina.com
Kangqiang Lin, MM, lkq1008@foxmail.com
About this study
Official title: Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study
The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.
Read the detailed description
This multi-center prospective cohort study investigates the relationship between emotional distress (ED) and treatment outcomes in patients receiving immune checkpoint inhibitor (ICI) therapy for hepatocellular carcinoma (liver cancer). Recent research suggests that emotional distress may influence how well cancer treatments work, particularly immunotherapy, but this connection hasn't been well studied in liver cancer patients.
Scientific Background: Liver cancer is a major global health concern, with increasing cases worldwide. While immunotherapy has emerged as a promising treatment option, not all patients respond equally well to this therapy. Understanding factors that might influence treatment success is crucial for improving patient care. Recent studies have shown that emotional distress can affect immune system function, which may impact how well immunotherapy works.
Study Design: The study includes three distinct cohorts of liver cancer patients:
Cohort 1: Patients with unresectable liver cancer starting first-line ICI therapy Cohort 2: Patients receiving ICI therapy after surgery (adjuvant therapy) Cohort 3: Patients receiving ICI therapy before surgery (neoadjuvant therapy)
Comprehensive Assessment Approach:
Emotional distress will be evaluated through multiple methods:
Self-reported questionnaires (PHQ-9 for depression and GAD-7 for anxiety) Professional clinical assessments (Hamilton Depression Scale, Hamilton Anxiety Scale, and Clinical Global Impression Scale) Quality of life measurements Biological markers of stress measured through blood tests
Treatment Monitoring: Participants will receive standard-of-care immunotherapy according to their treating physician's recommendations. The study will not influence treatment decisions but will carefully monitor:
Treatment response through regular imaging Side effects Quality of life Changes in emotional well-being Biological markers of stress and immune function Expected Outcomes and Impact: This study aims to: Determine if emotional distress affects treatment outcomes, Identify which patients might benefit from additional psychological support Understand the biological mechanisms linking stress and treatment response, Develop better strategies for supporting patients during immunotherapy Patient Safety and Support: While this is an observational study that doesn't change standard treatment, we recognize that discussing emotional health can be sensitive. The study includes: Regular monitoring of participants' emotional well-being, Access to mental health professionals if needed, Clear protocols for handling any psychological concerns that arise, Protection of patient privacy and confidentiality Long-term Goals: The findings from this study could lead to: Better ways to identify patients who might need extra support during treatment, New strategies to improve treatment effectiveness, More personalized approaches to cancer care that consider both physical and emotional health, Improved understanding of how psychological factors affect cancer treatment Duration and Follow-up: The study will enroll participants over three years, with each participant followed for up to three years. This allows us to understand both immediate and long-term relationships between emotional well-being and treatment outcomes.
Study Innovation: This is one of the first large-scale studies to: Examine the impact of emotional distress on immunotherapy outcomes in liver cancer, Use both patient self-assessments and professional clinical evaluations, Study this relationship across different stages of treatment.
- Conditions
- HCC - Hepatocellular Carcinoma, Psychological Distress, Immune Checkpoint Inhibitors (ICIs), Cancer, Treatment-Related, Unresectable Hepatocellular Carcinoma
- Being tested
- Psychological Stress Status
- Keywords
- Observational Study, Hepatocellular Carcinoma (HCC), Emotional Distress, Immune Checkpoint Inhibitors, Cancer Immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular, Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological Stress StatusOther
Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.
Psychological Stress StatusOther
Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.
Psychological stress statusOther
Psychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Unresectable HCC First-line ICI | This group includes participants with unresectable hepatocellular carcinoma who will receive first-line immune checkpoint inhibitor therapy. Participants must have BCLC stage B or C disease and Child-Pugh score A or B (≤7). They will receive standard-of-care immune checkpoint inhibitor therapy according to their physician's choice, either as monotherapy or in combination with other treatments. Emotional distress will be assessed before treatment initiation and during therapy using standardized questionnaires and clinical evaluations. Treatment response will be evaluated every 6-8 weeks using mRECIST criteria. Receives: Other: Psychological Stress Status | |
| Cohort 2: Resectable HCC Adjuvant ICI | This group includes participants with resectable hepatocellular carcinoma who have undergone curative surgery and will receive adjuvant immune checkpoint inhibitor therapy. They will begin immune checkpoint inhibitor therapy within 4-6 weeks after surgery. Emotional distress will be assessed before starting adjuvant therapy and during treatment. Disease-free survival will be monitored through regular follow-up visits and imaging. Receives: Other: Psychological Stress Status | |
| Cohort 3: Resectable HCC Neoadjuvant ICI | This group includes participants with resectable hepatocellular carcinoma who will receive immune checkpoint inhibitor therapy before planned surgery. They will receive immune checkpoint inhibitor therapy before surgery, with response assessed using mRECIST criteria. Emotional distress will be evaluated before and during treatment. Pathological complete response will be assessed in surgical specimens. Receives: Other: Psychological stress status |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival (PFS)
Time from treatment initiation to disease progression or death
Measured: Up to 24 months
Disease-Free Survival (DFS)
Time from surgery to disease recurrence or death
Measured: Up to 36 months
Pathological Complete Response (pCR) Rate
Percentage of participants achieving complete pathological response
Measured: At time of surgery (approximately 6-8 weeks after neoadjuvant therapy)
Secondary outcomes (9)
Overall Survival (OS)
Time from treatment initiation to death from any cause
Measured: Up to 36 months
Objective Response Rate (ORR)
Percentage of participants achieving complete or partial response
Measured: Up to 2 years (assessed every 6-8 weeks from from treatment initiation until disease progression or death from any cause)
Stress Biomarker Levels
Changes in cortisol and ACTH levels
Measured: From baseline up to 36 months (assessed every 3 months until study completion, disease progression, or death from any cause, whichever occurs first)
Safety and Adverse Events
Frequency and severity of adverse events
Measured: Throughout study duration (up to 36 months)
Health-Related Quality of Life measured by EORTC QLQ-C30 Total Score
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30) scores. The scale ranges from 0 to 100, where higher scores represent better quality of life for functional scales and global health status, but higher scores represent worse symptoms for symptom scales.
Measured: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years).
Changes in Depression Scores (PHQ-9)
Changes in Patient Health Questionnaire-9 (PHQ-9) depression scores from baseline
Measured: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Changes in Anxiety Scores (GAD-7)
Changes in Generalized Anxiety Disorder-7 (GAD-7) scores from baseline
Measured: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Changes in Depression Scores (HAMD)
Changes in Hamilton Depression Rating Scale (HAMD) scores from baseline
Measured: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Changes in Anxiety Scores (HAMA)
Changes in Hamilton Anxiety Rating Scale (HAMA) scores from baseline
Measured: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jan 2025
- Primary completion30 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HCC - Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Guilin Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Yaqun, Guilin Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141056
- Sponsor's protocol ID
- 2024IITLL-51
- Acronym
- SOLACE
- Status last verified
- Aug 2025
- First submitted
- 22 Dec 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ye L, Liao J, Lin K, Chen X, Su Y, Shi H, Wang T, Mo Q, Weng J, Li R, Jiang Z, Yu Y. Association between emotional distress and efficacy of immune checkpoint inhibitors in patients with hepatocellular carcinoma: a multicentre, prospective observational study protocol. BMJ Open. 2026 Jul 22;16(7):e110148. doi: 10.1136/bmjopen-2025-110148.
PubMed 42486514
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Emotional Stress on Immune Checkpoint Inhibitor Treatment Outcomes in Hepatocellular Carcinoma: A Multicohort Clinical Study
- ClinicalTrials.gov ID
- NCT07141056
- Acronym / sponsor ID
- SOLACE / 2024IITLL-51
- Conditions
- HCC - Hepatocellular Carcinoma, Psychological Distress, Immune Checkpoint Inhibitors (ICIs), Cancer, Treatment-Related, Unresectable Hepatocellular Carcinoma
- Keywords
- Observational Study, Hepatocellular Carcinoma (HCC), Emotional Distress, Immune Checkpoint Inhibitors, Cancer Immunotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Guilin Medical University, ChinaUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn if emotional distress affects how well liver cancer treatment works in people receiving immunotherapy. Emotional distress means feeling anxious or depressed. The study aims to answer whether having emotional distress before treatment or changes in emotional distress during treatment affect how well immunotherapy works to treat liver cancer. Researchers will compare participants with and without emotional distress to examine differences in how long the cancer stays under control, treatment response, and overall survival time. Study participants will complete mood and quality of life questionnaires, meet with mental health specialists for emotional assessments, undergo regular blood tests to measure stress hormones, have routine medical check-ups and scans to monitor their cancer status, and be followed for up to 3 years. The study includes three groups of people with liver cancer: those starting immunotherapy for cancer that cannot be removed by surgery, those receiving immunotherapy after surgery, and those receiving immunotherapy before surgery. To be eligible for participation, individuals must be 18 years or older, diagnosed with liver cancer, about to start immunotherapy treatment, and able to complete mood questionnaires.
Detailed description
This multi-center prospective cohort study investigates the relationship between emotional distress (ED) and treatment outcomes in patients receiving immune checkpoint inhibitor (ICI) therapy for hepatocellular carcinoma (liver cancer). Recent research suggests that emotional distress may influence how well cancer treatments work, particularly immunotherapy, but this connection hasn't been well studied in liver cancer patients.
Scientific Background: Liver cancer is a major global health concern, with increasing cases worldwide. While immunotherapy has emerged as a promising treatment option, not all patients respond equally well to this therapy. Understanding factors that might influence treatment success is crucial for improving patient care. Recent studies have shown that emotional distress can affect immune system function, which may impact how well immunotherapy works.
Study Design: The study includes three distinct cohorts of liver cancer patients:
Cohort 1: Patients with unresectable liver cancer starting first-line ICI therapy Cohort 2: Patients receiving ICI therapy after surgery (adjuvant therapy) Cohort 3: Patients receiving ICI therapy before surgery (neoadjuvant therapy)
Comprehensive Assessment Approach:
Emotional distress will be evaluated through multiple methods:
Self-reported questionnaires (PHQ-9 for depression and GAD-7 for anxiety) Professional clinical assessments (Hamilton Depression Scale, Hamilton Anxiety Scale, and Clinical Global Impression Scale) Quality of life measurements Biological markers of stress measured through blood tests
Treatment Monitoring: Participants will receive standard-of-care immunotherapy according to their treating physician's recommendations. The study will not influence treatment decisions but will carefully monitor:
Treatment response through regular imaging Side effects Quality of life Changes in emotional well-being Biological markers of stress and immune function Expected Outcomes and Impact: This study aims to: Determine if emotional distress affects treatment outcomes, Identify which patients might benefit from additional psychological support Understand the biological mechanisms linking stress and treatment response, Develop better strategies for supporting patients during immunotherapy Patient Safety and Support: While this is an observational study that doesn't change standard treatment, we recognize that discussing emotional health can be sensitive. The study includes: Regular monitoring of participants' emotional well-being, Access to mental health professionals if needed, Clear protocols for handling any psychological concerns that arise, Protection of patient privacy and confidentiality Long-term Goals: The findings from this study could lead to: Better ways to identify patients who might need extra support during treatment, New strategies to improve treatment effectiveness, More personalized approaches to cancer care that consider both physical and emotional health, Improved understanding of how psychological factors affect cancer treatment Duration and Follow-up: The study will enroll participants over three years, with each participant followed for up to three years. This allows us to understand both immediate and long-term relationships between emotional well-being and treatment outcomes.
Study Innovation: This is one of the first large-scale studies to: Examine the impact of emotional distress on immunotherapy outcomes in liver cancer, Use both patient self-assessments and professional clinical evaluations, Study this relationship across different stages of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Unresectable HCC First-line ICI | – | Other: Psychological Stress StatusThis group includes participants with unresectable hepatocellular carcinoma who will receive first-line immune checkpoint inhibitor therapy. Participants must have BCLC stage B or C disease and Child-Pugh score A or B (≤7). They will receive standard-of-care immune checkpoint inhibitor therapy according to their physician's choice, either as monotherapy or in combination with other treatments. Emotional distress will be assessed before treatment initiation and during therapy using standardized questionnaires and clinical evaluations. Treatment response will be evaluated every 6-8 weeks using mRECIST criteria. |
| Cohort 2: Resectable HCC Adjuvant ICI | – | Other: Psychological Stress StatusThis group includes participants with resectable hepatocellular carcinoma who have undergone curative surgery and will receive adjuvant immune checkpoint inhibitor therapy. They will begin immune checkpoint inhibitor therapy within 4-6 weeks after surgery. Emotional distress will be assessed before starting adjuvant therapy and during treatment. Disease-free survival will be monitored through regular follow-up visits and imaging. |
| Cohort 3: Resectable HCC Neoadjuvant ICI | – | Other: Psychological stress statusThis group includes participants with resectable hepatocellular carcinoma who will receive immune checkpoint inhibitor therapy before planned surgery. They will receive immune checkpoint inhibitor therapy before surgery, with response assessed using mRECIST criteria. Emotional distress will be evaluated before and during treatment. Pathological complete response will be assessed in surgical specimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients diagnosed with hepatocellular carcinoma (HCC) who are candidates for immune checkpoint inhibitor therapy. This includes three distinct groups: patients with unresectable HCC who are eligible for first-line immunotherapy (BCLC stage B or C disease), patients with surgically resected HCC who are candidates for adjuvant immunotherapy and patients with potentially resectable HCC who are candidates for neoadjuvant immunotherapy . The study will enroll participants regardless of gender, ethnicity, socioeconomic status, education level, or insurance status. A total of 700 participants will be enrolled across all three cohorts from multiple tertiary hospitals.
Key inclusion criteria (30 listed)
- Age ≥ 18 years
- Able to complete psychological questionnaires
- Child-Pugh liver function class A
- ECOG performance status ≤ 1
- Signed informed consent
Key exclusion criteria (23 listed)
- Currently taking antidepressant or anti-anxiety medications
- Previous diagnosis of psychiatric disorders
- Concurrent malignancy
- Unable to complete psychological assessments
- Previous systemic anti-tumor therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological Stress StatusPsychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up. | Other | Cohort 1: Unresectable HCC First-line ICI |
| Psychological Stress StatusPsychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up. | Other | Cohort 2: Resectable HCC Adjuvant ICI |
| Psychological stress statusPsychological stress status will be assessed using both self-reported and clinician-rated measures. Participants will be categorized into stressed and non-stressed groups based on the following criteria: Self-reported measures (either): PHQ-9 score ≥ 5 (depression symptoms) and/or; GAD-7 score ≥ 5 (anxiety symptoms) Clinician-rated measures (either): HAMD score ≥ 7 (mild depression) and/or HAMA score ≥ 7 (mild anxiety) Additional assessments: Clinical Global Impression Scale (CGI) EORTC QLQ-C30 (quality of life) Assessment timing: Baseline (before starting immunotherapy) After 2-3 cycles of treatment Every 3 months during follow-up. | Other | Cohort 3: Resectable HCC Neoadjuvant ICI |
Primary outcome
Progression-Free Survival (PFS)
Time frame: Up to 24 months
Time from treatment initiation to disease progression or death
Disease-Free Survival (DFS)
Time frame: Up to 36 months
Time from surgery to disease recurrence or death
Pathological Complete Response (pCR) Rate
Time frame: At time of surgery (approximately 6-8 weeks after neoadjuvant therapy)
Percentage of participants achieving complete pathological response
9 secondary outcomes
Overall Survival (OS)
Time frame: Up to 36 months
Objective Response Rate (ORR)
Time frame: Up to 2 years (assessed every 6-8 weeks from from treatment initiation until disease progression or death from any cause)
Stress Biomarker Levels
Time frame: From baseline up to 36 months (assessed every 3 months until study completion, disease progression, or death from any cause, whichever occurs first)
Safety and Adverse Events
Time frame: Throughout study duration (up to 36 months)
Health-Related Quality of Life measured by EORTC QLQ-C30 Total Score
Time frame: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years).
Changes in Depression Scores (PHQ-9)
Time frame: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Changes in Anxiety Scores (GAD-7)
Time frame: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Changes in Depression Scores (HAMD)
Time frame: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Changes in Anxiety Scores (HAMA)
Time frame: Baseline, 6 weeks, 9 weeks, then every 12 weeks through study completion (up to 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Derived from this study: PubMed 42486514Ye L, Liao J, Lin K, Chen X, Su Y, Shi H, Wang T, Mo Q, Weng J, Li R, Jiang Z, Yu Y. Association between emotional distress and efficacy of immune checkpoint inhibitors in patients with hepatocellular carcinoma: a multicentre, prospective observational study protocol. BMJ Open. 2026 Jul 22;16(7):e110148. doi: 10.1136/bmjopen-2025-110148.
- FDA Drug and Device ResourcesLink provided by the sponsor.
- MedlinePlus related topics: HCC StressLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HCC - Hepatocellular Carcinoma and Psychological Distress, run by Guilin Medical University, China at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Yaqun, MD. PhD (+ 86 18172681387, yyq0129@glmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07141056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.